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NCT00499616 · OUTCOME

Outcome of Patients With Stage 4S Neuroblastoma Who Are Unable to Undergo Biopsy for Biology-based Risk Assignment

Combination Chemotherapy and Surgery With or Without Isotretinoin in Treating Young Patients With Neuroblastoma · Source last updated 2021-07-06

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage survival
Interval / dispersion
95% Confidence Interval
Time frame
From baseline to up to 10 years

What was measured

Kaplan-Meier curves and lifetables of Event Free Survival (EFS) and Overall Survival (OS) rates will be generated to describe the outcome of the stage 4S infants unable to undergo biopsy.

Analysis population: Eligible and evaluable patients with Stage 4S neuroblastoma unable to undergo biopsy.

Groups in this outcome

Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)

8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients \< 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)4

Reported measurements

OS
Values in percentage survival · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)50.0Not reported1.099.0Not reported
EFS
Values in percentage survival · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)25.0Not reported067.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.0
        upper Limit
        99.0
        value
        50.0
    title
    OS
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        67.4
        value
        25.0
    title
    EFS
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    units
    Participants
description
Kaplan-Meier curves and lifetables of Event Free Survival (EFS) and Overall Survival (OS) rates will be generated to describe the outcome of the stage 4S infants unable to undergo biopsy.
dispersion Type
95% Confidence Interval
groups
  1. description
    8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients \< 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
    id
    OG000
    title
    Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)
param Type
NUMBER
population Description
Eligible and evaluable patients with Stage 4S neuroblastoma unable to undergo biopsy.
reporting Status
POSTED
time Frame
From baseline to up to 10 years
title
Outcome of Patients With Stage 4S Neuroblastoma Who Are Unable to Undergo Biopsy for Biology-based Risk Assignment
type
PRIMARY
unit Of Measure
percentage survival

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice